VARIOUS SURVEYS HAVE PREDICTED THAT CONDUCTING CLINICAL TRIAL IN THE UNITED STATES IS EXPENSIVE & CUMBERSOME:

“Pharmaceutical companies can spend 10 to 12 years and up to $900 million to bring a drug to market. About 45 percent of this cost is accrued during the clinical trial phase. Additionally, studies indicate that 75 percent of all trials conducted in the United States are behind schedule by one to six months”

Because pharmaceutical companies struggle with the following challenges:

1. Lengthy and complex clinical study design and planning process waste time and money.
2. Clinical trials often involve thousands of patients and hundreds of support staff
3. Inefficiencies and delays capturing patient data: consistent, streamlined capture of patient data is critical for success
4. Inability to connect to a wide variety of networking systems, clinical trial often involve interaction with numerous trial sites using desperate systems and processes
5. Difficulty in remaining compliant with FDA regulation. Stringent FDA regulations are placing more pressure on clinical trial management


CLINICAL TRIAL OVERSEAS:

• ICH-GCP Guide lines related services in other countries… Auditing services with ICH & FDA regulation is becoming increasingly more stringent the need to ensure compliance has never been more important. ASI- CROs are trained to assure that the progress & conduct of the study is according to protocols and FDA & ICH guidelines.